The Effect of a Reduced Noise Environment on the Response Time of the Anesthesia Provider

The Effect of a Reduced Noise Environment on the Response Time of the Anesthesia Provider to Auditory and Visual Alarms During Induction and Emergence From General Anesthesia

This project will investigate whether reduction in ambient light and elimination of noise during induction and emergence from anesthesia influences the response time of the anesthesia provider to auditory and visual alarms when compared to a standard operating room. In addition, the investigators will assess the cumulative level of noise exposure that providers experience during the perioperative period.

Study Overview

• Status: Completed
• Conditions: Noise Exposure
• Intervention / Treatment: Other: Reduced noise; Other: Normal

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Anesthesia providers that have agreed to participate.

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Noise reduction; Reduced operating room personnel, low ambient light and soft background music during induction and emergence from anesthesia.	Other: Reduced noise; All activity will cease when the patient enters the operating room and nonessential personnel will be removed. Ambient lighting will be reduced and communication devices muted.
Active Comparator: Control; Normal operating room environment.	Other: Normal; No change in the normal operating room environment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction response time	Response time of the anesthesia provider to the auditory/visual alarm during induction of anesthesia	Within 5 mins of patient entering the OR
Emergence response time	Response time of the anesthesia provider to the auditory/visual alarm during emergence from anesthesia	Within 5-15 mins after completion of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Noise exposure	Assess the cumulative level of noise exposure to the anesthesia provider during the entire surgery of a patient	Average of 30 mins - 3 hrs

Collaborators and Investigators

• Sponsor: Joshua Uffman
• Investigators: Principal Investigator: Richard Cartabuke, MD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2018
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: April 16, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB18-00227

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No